Events

Recall of Device Recall OMNI 8

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    27922
  • Event Risk Class
    Class 2
  • Event Number
    Z-0327-04
  • Event Initiated Date
    2003-12-15
  • Event Date Posted
    2004-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30750
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
  • Reason
    If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.
  • Action
    Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.

Device

Device Recall OMNI 8

Manufacturer

Roche Diagnostics Corp.
  • Manufacturer Address
    Roche Diagnostics Corp., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Source
    USFDA